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HHS/CMS RIN: 0938-AS04 Publication ID: Fall 2013 
Title: ●Clinical Laboratory Improvement Amendment (CLIA)--Clarification of Waived Test Descriptor (CMS-3271-P) 
Abstract: As a result of new technology, this proposed rule would clarify the description of a test to identify hidden cancers. The CLIA regulations published in 1992 included a list of simple manual tests that can be waived and would not be subject to the CLIA quality standards. Since then, technology has advanced significantly and there are now more sophisticated automated methods available for this test. These new tests are more difficult to perform and require additional training and interpretation, along with other quality checks to ensure that the results are accurate and to prevent potential harm to patients. It is intended that this rule clarify the difference between the manual test methods listed in the original regulations and the newer automated ones that must be categorized as more complex, and therefore are subject to the quality standards in CLIA. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 42 CFR 493 
Legal Authority: 42 USC 263a  
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2014   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Judith Yost
Director, Division of Laboratory Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S-2-09-27, Center for Clinical Standards and Quality, Mail Stop C2-21-16, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone:410 786-3531
Email: judith.yost@cms.hhs.gov

 
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